BMS Reports the US FDA Acceptance of sBLA and EMA’s Validation of MAA for Opdivo (nivolumab) to Treat Stage IIB or IIC Melanoma
- The US FDA has accepted the sBLA for Opdivo as monotx. in the adjuvant setting for completely resected stage IIB or IIC melanoma along with EMA validates the Type II variation MAA. The US FDA’s decision is expected in Oct 2023 while the submission is complete & the EMA will now initiate the review procedure
- The submissions were based on the P-III trial (CheckMate -76K) trial evaluating Opdivo (480mg, q4w for ~12mos.) vs PBO which showed a significant & clinical benefit in RFS & the safety profile was consistent with prior studies
- Opdivo is a PD-1 immune checkpoint inhibitor that harnesses the body’s immune system to restore anti-tumor immune response & was approved in 65+ countries, incl. the US, EU, Japan & China
Ref: Businesswire | Image: BMS
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